Tiêu chuẩn quốc tế
Số hiệu
Standard Number
EN ISO 16061:2009
Năm ban hành 2009
Publication date
Tình trạng
A - Còn hiệu lực
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Tên tiếng Anh
Title in English Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)
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Giá:
Price Liên hệ / Contact us
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Phạm vi áp dụng
Scope of standard This International Standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety, this International Standard gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.
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